Puncturable membrane for safety syringe

ABSTRACT

A safety syringe may define a variable fluid chamber and detached needle assembly. The variable fluid chamber may be hermetically sealed off from the environment or ambient air until the needle assembly is attached to a syringe body of the safety syringe. A proximal end of the variable fluid chamber is sealed off from the environment via a seal between a piston and syringe body. The distal end of the variable fluid chamber may be sealed off from the environment via a barrier covering the distal end of the syringe body. The barrier may be punctured to allow fluid to through therethrough at or about the same time when the needle assembly is attached to the distal end portion of the syringe body.

CROSS-REFERENCE TO RELATED APPLICATIONS

This applications claims the benefits of U.S. Provisional PatentApplication Ser. No. 60/857,088, the entire contents of which areincorporated herein by reference.

The entire contents of U.S. application Ser. No. 11/511,668, filed Aug.29, 2006 is expressly incorporated herein by reference. Additionally,the entire contents of U.S. Pat. No. 6,413,236, filed Jun. 20, 2000 toVan Dyke is expressly incorporated herein by reference. Also, the entirecontents of U.S. application Ser. No. 11/409,617, filed Apr. 24, 2006 isexpressly incorporated herein by reference.

STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT

Not Applicable

BACKGROUND

The present invention relates to a safety syringe wherein a variablefluid chamber is hermetically sealed off from contaminated ambient airuntil a needle assembly is attached to a syringe body such that fluidicmedication may be withdrawn from a medication vial and injected into apatient in a sterile manner.

FIG. 1 illustrates a conventional safety syringe with a detached needleassembly. During use, a medical professional may select the appropriatesized needle based on the fluidic medication to be administered to thepatient. Once the appropriate sized needle is selected, the needleassembly may be attached to the syringe body of the safety syringe.Unfortunately, a distal end of the syringe body is uncovered. As such,from the time that the syringe is removed from its packaging to the timethat the needle assembly is attached to the syringe body, ambient air isallowed to flow into a variable fluid chamber which houses the fluidicmedication right before the fluidic medication is injected into thepatient. The ambient air flowed into the variable fluid chamber maycontain viruses, bacteria or other unwanted contaminants which may helodged onto the inner surface of the variable fluid chamber. When thefluidic medication is withdrawn into the variable fluid chamber, thecontaminant lodged onto the inner surface of the variable fluid chambermay contaminate the fluidic medication to be injected into the patient.

Accordingly, there is a need in the art for a device and a method forinjecting fluidic medication into the patient in a sterile manner.

BRIEF SUMMARY

The safety syringe discussed herein addresses the needs discussed above,discussed below and those that are known in the art.

The safety syringe provides a sterile environment in which the fluidicmedication may be withdrawn from a medication container and subsequentlyinjected into the patient. More particularly, the safety syringe mayhave a barrier disposed at a distal end portion of a syringe body of thesyringe. The barrier provides an impermeable air barrier between theenvironment (contaminated ambient air) and the variable fluid chamber.The barrier may be punctured at or about the same time when a needleassembly is attached to the syringe body. When the barrier is punctured,the needle assembly then acts as a cover such that contaminated ambientair does not enter into the variable fluid chamber after the barrier ispunctured by the needle assembly. As such, at no time during the processof removing the syringe from its packaging, attaching the needleassembly to the syringe body, withdrawing fluidic medication from amedication container and injecting the patient with the fluidicmedication was the variable fluid chamber exposed or allowed to haveambient air flow therein. Hence, the fluidic medication injected intothe patient is performed in a sterile manner.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the various embodimentsdisclosed herein will be better understood with respect to the followingdescription and drawings, in which like numbers refer to like partsthroughout, and in which:

FIG. 1 is a perspective view of a prior art safety syringe;

FIG. 2 is a perspective view of a safety syringe with a barrier and adetached needle assembly which is attachable to the syringe body;

FIG. 3 is a front cross-sectional view of the safety syringe shown inFIG. 2;

FIG. 4 is an alternate embodiment of attaching the harrier to thesyringe body;

FIG. 5 is a bottom view of the barrier illustrating score lines formingeight pie-shaped pieces wherein the score lines are depressions formedin the barrier to control tearing, ripping or weakening of the barrier;

FIG. 6 illustrates the pie shaped pieces shown in FIGS. 2 and 5 when thebarrier is punctured by the needle assembly;

FIG. 7 is a bottom view of the barrier illustrating an alternateconfiguration of the score lines;

FIG. 8 is a bottom view of the barrier illustrating the score lineshaving a wavy configuration; and

FIG. 9 is a front cross-sectional view of a safety syringe wherein thebarrier is attached to an inner surface of the syringe body.

DETAILED DESCRIPTION

Referring now to the drawings, FIG. 2 is a perspective view of a safetysyringe 10. In particular, the safety syringe 10 may comprise a plungerassembly 12 partially disposed within a syringe body 14. Fingerplatforms 16 may be attached to a proximal end of the syringe body 14 toassist the user in traversing the plunger assembly 12 between aretracted position and a forward position. The safety syringe 10 mayalso comprise a detached needle assembly 18 which may be attached to thesyringe body. One benefit of having the needle assembly 18 initiallydetached from the syringe body 14 and a selected needle assembly 18attachable to the syringe body is that a medical professional may attachan appropriately sized needle 20 to the syringe body 14 depending on theparticular mediation to be administered to the patient.

The safety syringe 10 is directed to a device and a method formaintaining sterility of fluidic medication during the entire process ofwithdrawing fluid medication from a medication container and injectingthe fluidic medication to the patient. The safety syringe 10accomplishes this by providing a barrier 22 between the environmentwhich contains contaminated ambient air and a sterile variable fluidchamber 26.

In particular, the safety syringe 10 may be provided to a medicalprofessional. The needle assembly 18 may initially be detached from thesyringe body 14. Moreover, the plunger assembly 12 may be initiallypositioned in a retracted position when provided to the medicalprofessional. As used herein, a retracted position of the plungerassembly is where a piston 28 of the plunger assembly 12 is closer to aproximal end of the syringe body 14 compared to a distal end portion 30of the syringe body 14. When the safety syringe 10 is assembled by themanufacturer, the safety syringe 10 is also sterilized to kill oreliminate harmful or potentially harmful viruses, bacteria and otherunwanted contaminants that may be on or in the safety syringe 10. Moreparticularly, during the sterilization process, the inner surface of thevariable fluid chamber 26 is sterilized. In particular, the innersurface of the variable fluid chamber 26 may be defined by a distal end32 of the piston 28, an inner surface 34 of the syringe body 14 and aproximal surface 36 of the barrier 22.

In use, to administer a fluidic medication to a patient, the needleassembly 18 is attached to the distal end portion 30 of the syringe body14. At or about the same time, the barrier 22 is punctured to allowfluidic medication to be drawn into the variable fluid chamber 26 andsubsequently ejected out of the variable fluid chamber 26 and injectedinto the patient via the needle 20.

One of the many important aspects of the safety syringe 10 is that theinner surface of the variable fluid chamber 26 does not come intocontact with the contaminated ambient air 24 during the process ofattaching the needle assembly 18 to the syringe body 14. Before theneedle assembly 18 is attached to the syringe body 14, the barrier 22prevents contaminated ambient air 24 from entering into the variablefluid chamber 26. The barrier 22 is punctured to allow fluid and/or airto enter into or escape out of the variable fluid chamber 26 at or aboutthe same time that the needle assembly 18 is attached to the syringebody 14. At such time, the needle assembly 18 then behaves as a coverafter the barrier 22 is punctured such that ambient air does not enterinto the variable fluid chamber 26 and possibly contaminate the variablefluid chamber 26 due to airborne viruses, bacteria or unwantedcontaminants in the ambient air 24.

After the needle assembly 18 is attached to the syringe body 14, thefluidic medication may be withdrawn from a medication vial and beadministered to the patient. In particular, the needle 20 of the syringe10 may be inserted into a medication container or vial. At this time,the plunger assembly may be traversed toward the forward position. Theforward position is defined where the piston 28 is closer to the distalend portion 30 of the syringe body 14 compared to a proximal end of thesyringe body 14. As the plunger assembly 12 is traversed toward theforward position, sterilized air contained in the variable fluid chamber26 is transferred into the medication container. Such transfer ofsterilized air 38 increases the pressure within the medication containerto assist in withdrawal of the fluidic medication therefrom. Themedication container and safety syringe 10 may now be inverted such thatthe medication container is positioned over the safety syringe 10. Adistal tip 40 of the needle 20 may be positioned within the fluidicmedication contained in the medication container. Now the plungerassembly 12 may be traversed back toward the retracted position. Suchretraction of the plunger assembly 12 traverses the fluidic medicationcontained in the medication container into the variable fluid chamber 26of the safety syringe 10. As you will note, the fluidic medication inthe variable fluid chamber 26 was not exposed to ambient air 24. Themedical professional may remove the needle 20 from the medicationcontainer and remove any sterilized air 38 from within the variablefluid chamber by inverting the safety syringe 10, tapping on syringebody 14 to urge the sterilized air 38 toward the needle 20, and thenslightly traversing the plunger assembly 12 toward the forward positionto eject the sterilized air 38 and a negligible amount of the fluidicmedication out of the variable fluid chamber 26 and the needle assembly18. At this time, the medical professional may inject the patient withthe fluidic medication contained in the variable fluid chamber 26.

In an aspect of the safety syringe 10, the needle assembly 18 may beattachable to the to the syringe body 14 in a plurality of differentmethods known in the art, discussed herein and those that are developedin the future. By way of example and not limitation, as shown in FIG. 3,the needle assembly 18 may have threads 42 disposed at a proximal endportion 44 of the needle assembly 18. Mating threads 46 may be formed atthe distal end portion 30 of the syringe body 14. More particularly, themating threads 46 may be formed on an inner surface 34 of the syringebody 14, whereas, the threads 42 of the needle assembly 18 may be formedon an outer surface of the proximal end portion 44 of the needleassembly 18. To attach the needle assembly 18 to the syringe body 14,the threads 42 may be threaded onto the mating threads 46. To lock theneedle assembly 18 onto the syringe body 14, the needle assembly 18 maybe formed with a stop flange 48. As the needle assembly 18 is threadedinto the syringe body 14, the stop flange 48 may eventually contact thedistal end portion 30 of the syringe body 14. The needle assembly 18 maythen be cinched or tightened onto the syringe body 14 to insurefrictional attachment between the needle assembly 18 and the syringebody 14. The above description of attaching the needle assembly 18 tothe syringe body 14 is one embodiment of attaching the needle assembly18 to the syringe body 14. The safety syringe 10 discussed herein shouldnot be limited only to this embodiment but also contemplates any othermethods and embodiments.

In an aspect of the safety syringe 10, various types of barriers 22 arecontemplated. By way of example and not limitation, as shown in FIG. 3,the barrier 22 may be an air impermeable membrane disposed over thedistal end portion 30 of the syringe body 14. The air impermeablemembrane may he hermetically sealed about the outer periphery of thedistal end portion 30 of the syringe body 14. Such seal is identified asreference numeral 50 in FIG. 3. The seal 50 may be formed via coldadhesive, hot adhesive, sonic welding as well as other methods known inthe art or developed in the future. The air impermeable membraneprevents non-sterile air of the environment from entering into thevariable fluid chamber 26 after the safety syringe 10 is removed fromits packaging and prior to mounting of the needle assembly 18 onto thesyringe body 14.

In another aspect of the safety syringe 10, as shown in FIG. 4, thebarrier 22 may be attached to the distal end 52 of the syringe body 14.Such attachment may be made by cold adhesive, hot adhesive, sonicwelding, as well as other methods that may be know in the art ordeveloped in the future. The seal between the barrier 22 or airimpermeable membrane and the distal end 52 of the syringe body 14 may beidentified as reference numeral 54 in FIG. 4.

In an aspect of the safety syringe 10, the puncturing of the barrier 22may be controlled. In particular, as shown in FIG. 2 and FIG. 5, thepuncturable barrier 22 may have a plurality of score lines 56. The scorelines urge the puncturable barrier 22 to tear or weaken at the scorelines 56 to permit fluid to pass through the barrier 22. The score lines56 may be depressions formed on a proximal or distal side of the barrier22. As shown in FIG. 6, when the needle assembly 18 (not shown in FIG.6) is attached to the syringe body 14, pie-shaped pieces 58 of theharrier 22 are pushed into the variable fluid chamber 26. The pie shapedpieces 58 are disposed between the threads 42 of the needle assembly 18and the mating threads 46 of the syringe body 14. Fluid (e.g., fluidicmedication) may now pass into or out of the variable fluid chamber 26.

Although the score lines 56 as shown in FIG. 5 are formed as in aplurality of pie-shaped pieces 58, other configurations of the scorelines 56 are contemplated. By way of example and not limitation, thescore lines 56 may be formed on the puncturable barrier 22 as shown inFIG. 7. FIG. 8 shows an alternative embodiment of a differentconfiguration of the score lines 56. As shown, each score line 56 mayhave a wavy pattern.

In an aspect of the barrier 22, the barrier 22 may be fabricated from anair impermeable material. By way of example and not limitation, theimpermeable material may be plastic, paper, rubber, cloth, etc. Thebarrier 22 may be perforated but still be characterized as impermeableso long as a free flow of ambient air is not allowed to pass through thebarrier 22 into the variable fluid chamber 26.

In another aspect of the safety syringe 10, as shown in FIG. 9, thebarrier 22 may extend across the inner periphery of the syringe body 14above the threads 42 of the mating threads 46 of the distal end portion30 of the syringe body 14. To mount the needle assembly 18 to thesyringe body 14, the threads 42 of the needle assembly 18 is threadedonto the mating threads 46. The needle assembly 18 is threaded into thesyringe body 14 until the stop flange 48 contacts the distal end 52 ofthe syringe body 14. At or about the same time, a protrusion 60 of theneedle assembly 18 may puncture the barrier 22. By way of example andnot limitation, the protrusion 60 may at least slightly tear or weakenthe barrier 22 to allow the fluidic medication to enter into or escapeout of the variable fluid chamber 26. The barrier 22 may becharacterized as punctured if the barrier 22 is torn or weakened so asto permit fluid to permeate through the barrier 22.

In an aspect of the safety syringe 10, the syringe 10 may be asterilized vacuum assisted retractable safety syringe as discussed inU.S. application Ser. No. 11/511,668 ('668 application), filed Aug. 29,2006, the entire content of which is incorporated herein by reference.The '688 application discusses how fluidic medication is injected intothe patient in a sterile manner if the needle assembly is attached tothe syringe body. In this regard, the discussion of the '668 applicationmay he employed in the safety syringe 10 with detached needle assemblydiscussed herein after the detached needle assembly 18 is attached tothe syringe body 14. Additionally, the safety syringe 10 may be a vacuumassisted retractable safety syringe as discussed in U.S. Pat. No. 6,413,236, filed Jun. 20, 2000 to Van Dyke, the entire content of which isincorporated herein by reference.

The safety syringe 10 may have a variable vacuum compartment 62 (seeFIG. 3). When the plunger assembly 12 is in the retracted position, thevariable vacuum compartment has a pressure equal to ambient pressure. Asthe plunger assembly 12 is traversed toward the forward position, thevariable vacuum compartment 62 increases in volume but additional airmolecules are not introduced into the variable vacuum compartment 62.The reason is that there is a seal between the piston 28 and the innersurface 34 of the syringe body 14 as well as a seal between a shaft 64and proximal end of the syringe body 14. One benefit of the vacuumassisted retractable safety syringe 10 is that the inner surface of thevariable fluid chamber 26 will not become contaminated by introductionof contaminants via the proximal end of the syringe body 14. Ambient airdoes not enter into the variable vacuum compartment 62 through theproximal end of the syringe body 14.

Although the variable vacuum compartment 62 and the variable fluidchamber 26 are separate compartments, during the process of injectingthe patient with fluidic medication via the safety syringe 10, thevariable fluid chamber 26 and the variable vacuum compartment 62 share acommon surface, namely, the inner surface 34 of the syringe body. Forexample, the plunger assembly 12 is traversed between two positions,namely, the retracted position and the forward position. When theplunger assembly 12 is in the retracted position, the variable fluidchamber 26 typically has a larger volume compared to the variable vacuumcompartment 62. When the plunger assembly 12 is traversed toward theforward position, the volume of the variable vacuum compartment 62increases and the volume of the variable fluid chamber 26 decreasesbecause the distal end 28 slides downward against the inner surface 34of the syringe body 14. Accordingly, a portion of the inner surface 34of the syringe body which used to define the variable fluid chamber 26now at least partially defines the variable vacuum compartment 62.

If ambient air 24 were to enter into the variable vacuum compartment 62via the proximal end of the syringe body 14, then contaminants containedin the ambient air 24 may be lodged onto the inner surface 34 of thesyringe body. As the plunger assembly 12 is traversed between theretracted position and the forward position, the lodged contaminants onthe inner surface 34 of the syringe body may eventually enter into thevariable fluid chamber and thereby contaminate any fluidic medicationdrawn into the variable fluid chamber 26.

A benefit of the vacuum assisted retractable safety syringe is that thevariable vacuum compartment 62 remains in a sterile state throughout theentire process of injecting the patient with fluidic medication becauseambient air is not allowed into the variable vacuum compartment 62 viathe proximal end of the syringe body 14.

Combining the vacuum assisted retractable safety syringe 10 with thebarrier 22 provides a complete sterile environment in which the fluidicmedication may be withdrawn into the variable fluid chamber 26 andsubsequently injected into the patient without concern that the fluidicmedication may become contaminated by exposure to the ambient air 24 orto contaminants that may have entered into the variable fluid chamber 26via the proximal end of the syringe body 14.

In an aspect of the syringe 10, the detached needle assembly 18 may beattachable to the syringe body 14, as discussed in U.S. application Ser.No. 11/409,617, filed Apr. 24, 2006, the entire contents of which areexpressly incorporated herein by reference. Additionally, the needle 20of the needle assembly 18 may be retractable into the syringe body 14 asshown in U.S. application Ser. No. 11/409,617. Moreover, the barrier 22may be attached to the distal end portion 30 of the syringe body 14shown in FIGS. 1-5 of U.S. application Ser. No. 11/409,617.

The above description is given by way of example, and not limitation.Given the above disclosure, one skilled in the art could devisevariations that are within the scope and spirit of the inventiondisclosed herein. Further, the various features of the embodimentsdisclosed herein can be used alone, or in varying combinations with eachother and are not intended to be limited to the specific combinationdescribed herein. Thus, the scope of the claims is not to be limited bythe illustrated embodiments.

1. A safety syringe for injecting a patient with fluidic medication in asterile manner, the syringe comprising: a plunger assembly having apiston and a shaft; a syringe body, the syringe body having a proximalportion and a distal portion, the piston and shaft partially disposedwithin the syringe body, the piston being traversable between aretracted position and a forward position within the syringe body, thepiston and syringe body defining a sterile variable fluid chamber, thesterile variable fluid chamber disposed on a distal side of the pistonwith sterile gas disposed therein; a barrier attached to a distal endportion of the syringe body and located distally from the variable fluidchamber, the barrier configured, before a needle is attached to thesyringe, to prevent air transfer between an external environment and thesterile variable fluid chamber and to maintain sterility of the variablefluid chamber; and a detached needle assembly, having a needle end and asyringe end without a needle, attachable at the syringe end to thedistal portion of the syringe body and operative when attached at thesyringe end to the distal portion of the syringe body to puncture thebarrier to allow fluidic medication to flow into or out of the sterilevariable fluid chamber through the needle assembly.
 2. The syringe ofclaim 1 wherein the barrier is configured to be torn when it ispunctured.
 3. The syringe of claim 1 wherein the barrier is airimpermeable and hermetically sealed to the distal end portion of thesyringe body.
 4. The syringe of claim 1 wherein the barrier is weakenedin a pattern and operative to rupture in accordance with the patternupon puncturing by attachment of the detached needle assembly to thesyringe body.
 5. The syringe of claim 4 wherein the pattern is aplurality of score lines or perforations.
 6. The syringe of claim 4wherein the pattern has a configuration of a pie cut into a plurality ofpieces.
 7. The syringe of claim 1 wherein the barrier is attached to thesyringe body closer to the distal portion than to the proximal portionof the syringe body.
 8. A method of injecting a fluid in a person, themethod comprising the steps of: receiving a syringe body with a barrierattached to a distal end portion of the syringe body, the barrierconfigured to prevent free flow of air transfer between an environmentand a sterile variable fluid chamber of the syringe body prior toattachment of a needle assembly to the syringe body, the sterilevariable fluid chamber disposed on a distal side of a piston, the pistonbeing disposed in a retracted position with the syringe body and sterilegas disposed within the sterile variable fluid chamber; attaching aneedle assembly to the distal end portion of the syringe body, theneedle assembly having a needle end and a syringe end without a needle,the syringe end of the needle assembly configured to puncture thebarrier when the needle assembly is attached to the syringe body inorder to allow fluidic medication to flow into or out of the sterilevariable fluid chamber through the needle assembly; puncturing thebarrier with the syringe end of the needle assembly, to permit flow offluid through the punctured barrier; inserting a needle of the needleassembly into a container containing fluidic medication; traversing apiston toward the distal end portion of the syringe body to transfer thesterile gas within the sterile variable fluid chamber into the containerto pressurize the container and assist in subsequent withdrawal of thefluidic medication contained in the container; positioning an opening ofthe needle within the fluidic medication in the container; transferringthe fluid in the container into the sterile variable fluid chamber; andinjecting the person with the fluid in the sterile variable fluidchamber. 9.-12. (canceled)
 13. The syringe of claim 1, furthercomprising: first threads disposed on an inner surface of the syringebody; and second threads disposed on an outer surface of the needleassembly, the second threads configured to mate with the first threads.14. The syringe of claim 14, wherein the needle assembly is configuredto puncture the barrier when the second threads on the needle assemblyare threaded onto the first threads.
 15. The syringe of claim 1, whereinthe barrier is disposed within the syringe body.
 16. The syringe ofclaim 1, wherein the barrier is disposed at a distal end of the syringebody.
 17. The method of claim 8, wherein inserting the needle of theneedle assembly further comprises threading the needle assembly ontomatching threads disposed on the body of the syringe.